Clinical trial · Interventional
Study Comparing Limited and Extensive Neck Surgery in Oral Cancer Patients With Neck Spread
Extent of Neck Treatment in Clinically N1 Oral Cancer: A Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Oral cavity squamous cell carcinoma (OCSCC) frequently metastasizes to cervical lymph nodes, and the extent of neck dissection remains an area of ongoing debate in patients with clinically node-positive (cN1) disease. While modified neck dissection (MND, levels I-V) is widely practiced, selective neck dissection (SND, levels I-IV) may provide equivalent oncologic outcomes with reduced surgical morbidity. However, high-quality randomized evidence comparing these approaches is lacking. The ExteNT N1 Trial is a prospective, randomized, open-label, parallel-group clinical trial designed to compare selective neck dissection (levels I-IV) with modified neck dissection (levels I-V, preserving the spinal accessory nerve, internal jugular vein, and sternocleidomastoid muscle) in patients with resectable cN1 oral cavity squamous cell carcinoma. Eligible participants will be randomized in a 1:1 ratio to either treatment arm. The primary endpoint is 3-year regional recurrence-free survival (RRFS), along with postoperative quality of life measured using the Neck Dissection Impairment Index (NDII). Secondary endpoints include overall survival, disease-free survival, level-wise nodal involvement, nodal yield, shoulder function (Constant-Murley Score, SPADI, and Arm Abduction Score), postoperative complications including chyle leak, and other surgical morbidities. This trial aims to generate level I evidence regarding the optimal extent of neck dissection for cN1 OCSCC, balancing oncologic safety with preservation of postoperative function and quality of life.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oral Cavity Squamous Cell Carcinoma | Oral Cavity Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Modified Neck Dissection (Levels I-V) | Procedure | — | UNRESOLVED |
| Selective Neck Dissection (Levels I-IV) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm 1- Selective neck dissection level I to level IV
- description
- Participants randomized to this arm will undergo surgical resection of the primary oral cavity squamous cell carcinoma along with ipsilateral selective neck dissection involving cervical lymph node levels I-IV. Contralateral neck management, reconstruction, and adjuvant therapy will be performed according to standard institutional protocols and final histopathological findings.
- interventionNames
- Procedure: Selective Neck Dissection (Levels I-IV)
- type
- ACTIVE_COMPARATOR
- label
- Arm 2- Modified Neck Dissection (Levels I-V)
- description
- Participants randomized to this arm will undergo surgical resection of the primary oral cavity squamous cell carcinoma along with ipsilateral modified neck dissection involving cervical lymph node levels I-V while preserving the spinal accessory nerve, internal jugular vein, and sternocleidomastoid muscle whenever oncologically appropriate. Contralateral neck management, reconstruction, and adjuvant therapy will be performed according to standard institutional protocols and final histopathological findings.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proven squamous cell carcinoma of oral cavity will be included * Clinical stage T1-T4, N1, M0 * cN1 neck on clinical examination and imaging (CT/MRI) * Single node which is FNAC proven without any other significant nodes. * Patients with ASA grade II and I. * Understands the protocol and able to give informed consent. Exclusion Criteria: * Recurrent cases * Multiple significant nodes * Nodes clinical/radiological with ENE * Single metastatic node at level III/IV/V * Single metastatic node with other suspicious nodes * Patients with a history of head and neck radiation therapy treatment * Previous history of any malignancy
References
Publications (4)
- RESULTPantvaidya GH, Pal P, Vaidya AD, Pai PS, D'Cruz AK. Prospective study of 583 neck dissections in oral cancers: implications for clinical practice. Head Neck. 2014 Oct;36(10):1503-7. doi: 10.1002/hed.23494. Epub 2014 Jan 13. PMID 23996343
- RESULTLiang L, Zhang T, Kong Q, Liang J, Liao G. A meta-analysis on selective versus comprehensive neck dissection in oral squamous cell carcinoma patients with clinically node-positive neck. Oral Oncol. 2015 Dec;51(12):1076-81. doi: 10.1016/j.oraloncology.2015.10.005. Epub 2015 Oct 23. PMID 26500065
- RESULTHashmi SS, Abbas A, Bukhari A, Saeed J, Shafqat A, Siddique AH, Buksh AR, Murtaza G. Selective Neck Dissection for Node-Positive Oral Cavity Squamous Cell Carcinoma: A Retrospective Cohort Study. Int Arch Otorhinolaryngol. 2022 Feb 22;26(4):e630-e635. doi: 10.1055/s-0041-1741437. eCollection 2022 Oct. PMID 36405475
- RESULTShin YS, Koh YW, Kim SH, Choi EC. Selective neck dissection for clinically node-positive oral cavity squamous cell carcinoma. Yonsei Med J. 2013 Jan 1;54(1):139-44. doi: 10.3349/ymj.2013.54.1.139. PMID 23225810